Recall Z-2137-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
| Date | Apr 21, 2020 |
| Status | Terminated |
| Reason | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections |
| Root cause | Process control |
| Action | Philips issued Urgent Medical Device Removal (FSNB6100215A) on 4/21/20 to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Upon receipt of this notification, promptly locate the affected XL M4735A device listed on page 3, Appendix A, of this notification and remove them from clinical use immediately. A Philips representative will contact you to confirm that each device has been PHILIPS removed from service. Philips intends to take no further action |
| Quantity | 130 units (US 126; OUS 4) |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.